Chronic insomnia
Conditions
Interventions
Study One A Group: CBT-I Only Group:Cognitive Behavioral Therapy for Insomnia (CBT-I)
Study One B Group: CBT-I plus HIIT Group:Cognitive Behavioral Therapy for Insomnia (CBT-I) plus High-Intensity Interval Training (HIIT)
Study One C Group: CBT-I plus Smart Sleep Bed Group:Cognitive Behavioral Therapy for Insomnia (CBT-I) plus Smart Sleep Bed Intervention
Study One D Group: CBT-I plus HIIT and Smart Sleep Bed Group:Cognitive Behavioral Therapy for Insomnia (CBT-I) plus High-Intensity Interval Training (HIIT) and Smart Sleep Bed Intervention
Study Two Multimodal Intervention Group:Cognitive Behavioral Therapy for Insomnia (CBT-I) plus High-Intensity Interval Training (HIIT) and Smart Sleep Bed
Study Two Control Group:Routine Sleep Health Education
Study Three Multimodal Intervention Group (Athletes):CBT-I plus Smart Sleep Bed
Study Three CBT-I Group (Athletes):Standardized CBT-I Treatment
Study Three Control Group (Athletes):Sleep Health Education (Online Course and Self-Study Manual)
Sponsors
China Institute of Sport Science
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Research 1: 1. Insomnia patients meeting the diagnostic criteria above; 2. Aged between 18 and 55 years; 3. Sleep disturbances and related daytime symptoms occur at least 3 times per week for at least 3 months; 4. Physical activity level assessed by the International Physical Activity Questionnaire (IPAQ) is low; 5. Condition remains stable, and original lifestyle habits (e.g., diet, medication, exercise) are maintained throughout the intervention and follow-up periods; 6. Possess good communication skills and treatment compliance to cooperate with assessments and treatments throughout the entire process; 7. Have not received other interventions, such as physical therapy or psychotherapy; 8. Voluntarily participate in the clinical trial and sign the informed consent form. Research 2: 1. Insomnia patients meeting the diagnostic criteria above; 2. Aged between 18 and 55 years; 3. Sleep disturbances and related daytime symptoms occur at least 3 times per week for at least 3 months; 4. Physical activity level assessed by the International Physical Activity Questionnaire (IPAQ) is low; 5. Condition remains stable, and original lifestyle habits (e.g., diet, medication, exercise) are maintained throughout the intervention and follow-up periods; 6. Possess good communication skills and treatment compliance to cooperate with assessments and treatments throughout the entire process; 7. Have not received other interventions, such as physical therapy or psychotherapy; 8. Voluntarily participate in the clinical trial and sign the informed consent form. Research 3: 1. Professional cyclists aged 18-35 years, reaching the level of National Sports Master or higher; the diagnosis of CI is determined jointly according to ICD-11 and the "Chinese Guidelines for Diagnosis and Treatment of Insomnia in Adults (2023 Edition)": insomnia symptoms persist for >=3 months, and currently in a regular training cycle; 2. Possess good communication skills and treatment compliance to cooperate with assessments and treatments throughout the entire process.
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria for Study One and Two (1) Insomnia caused by certain drugs or substances, or history of drug/alcohol abuse/dependence; (2) Participants with serious somatic diseases, neurological diseases, musculoskeletal system diseases, other medical conditions, or those with exercise (or HIIT) contraindications; (3) Diagnosed with comorbid mental disorders (such as schizophrenia or bipolar disorder) according to the Mini-International Neuropsychiatric Interview (M.I.N.I.), and Patient Health Questionnaire (PHQ-9) >=20 scores and/or Generalized Anxiety Disorder (GAD-7) scores >=15; (4) Participants at high risk of serious injury due to sleep deprivation (e.g., operators of heavy machinery); (5) Those who habitually engage in strenuous exercise within 2~4 hours before bedtime; (6) Those who habitually drink stimulating beverages such as coffee, strong tea before bedtime, and smokers/alcoholics; (7) Obese participants (BMI>=30kg/m^2), male waist-to-hip ratio (WHR) >=0.9/female WHR>=0.88, pregnant or planning pregnancy in the next 6 months; (8) Existence of other sleep disorder diagnoses (obstructive sleep apnea, periodic limb movement, narcolepsy, etc.) or positive screening for potential sleep disorders in questionnaire assessment; (9) Night shifts, evening shifts, early morning shifts, or rotating shift work; (10) Currently receiving insomnia treatment from health professionals/ participating in online insomnia treatment, and participating in other trials simultaneously. 2. Exclusion Criteria for Study Three (1) Insomnia caused by certain drugs or substances; (2) Currently or 3 months ago received other interventions targeting sleep problems, such as drug treatment, physical therapy, etc.; (3) Cross-time-zone travel during study period (time difference >=3 hours) or shift training arrangement (night training >=2 times/week); (4) Insomnia athletes with severe anxiety and depression: PHQ-9 >=20 scores and/or GAD-7 >=15 scores; (5) Recent major life events (such as injury/surgery, family changes, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Insomnia Severity Index;Sleep Status; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep Parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Sleep Efficiency, Sleep Quality);Autonomic Function and Sleep Monitoring Parameters (SDNN, RMSSD, HF, LF/HF, Sleep Duration);Depressive Symptoms;Anxiety Symptoms;Beliefs and Attitudes Related to Sleep;Daytime Symptoms and Impacts;Biomarkers (Adenosine, BDNF Levels);Pittsburgh Sleep Quality Index;Sleep Efficiency and HRV Parameters (SDNN, RMSSD, HF Power);Cognitive Function (Selective Attention, Episodic Memory);BDNF Levels;Sleep Continuity Parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Sleep Efficiency, HRV);Stress and Recovery Status;Athletic Performance;Sports Injury Incidence; | — |
Countries
China
Contacts
Public ContactCui Xinwen
China Institute of Sport Science
Outcome results
None listed